Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
Phase 4
Completed
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00154206
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Recipients of a primary renal transplantation
- Recipients of a renal transplantation only
Exclusion Criteria
- Recipients of a multi-organ transplantation
- Unable to take an oral medication
- Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
Other protocol-defined inclusion / exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
- Secondary Outcome Measures
Name Time Method Within the 6 and 12 months post transplantation Incidence of acute rejection resistant to steroids Incidence of graft loss and death Renal function by creatinine and creatinine clearance (Schwartz formula) Incidence of premature study drug discontinuation due to safety reason Pharmacokinetic profile of Myfortic. Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland